Various blood vessels and organs can be pierced or cut in connection with numerous surgical procedures or as a result of an accidental trauma. Examples of such surgical procedures include percutaneous transluminal coronary angioplasty (PTCA), angiography, biopsies, anastomosis procedures, as well as various neuro-interventional access procedures. After the surgery is complete or after accidental trauma, the treatment site, e.g., the puncture, cut, or wound, is closed. Surgical methods such as suturing, stapling, or gluing can be used to close the puncture, cut, or wound. In some cases, the treatment site can be closed by natural coagulation and without the aid of sutures, staples, glue, or the like.
Many surgical procedures can be performed using minimally invasive techniques such as those that require catheterization. During catheterization procedures in general, a physician or nurse will create an opening in an artery or other vessel using a conventional catheter introducer or dilator. The artery is accessed through an incision or puncture through the skin and muscle tissue of the patient. Depending upon the type of procedure and the size of the catheter that is used, the size of the opening will vary. Additionally, a further enlargement of the incision or puncture will often occur as the catheter is twisted or otherwise manipulated while being advanced through the body of the patient.
Angiography and angioplasty are examples of surgical procedures that are performed using catheters. Angiography is a diagnostic procedure in which a dye is injected into an artery, such as the femoral artery, to detect coronary disease. PTCA, or angioplasty, is a therapeutic procedure involving the inflation of a balloon in an artery, such as the coronary artery, for the purpose of clearing arterial occlusions. During catheterization, an incision is made in the femoral artery, and a balloon catheter is inserted and fed to the location of the occlusion in the coronary artery. The balloon is inflated and deflated in an attempt to open the occlusion in the artery. Alternatively, a rotational tip catheter may also be used to remove plaque buildup utilizing a technique known as differential cutting. Arterial catheterization procedures are generally performed through a puncture or an incision at the entry point of the catheter which must be closed once the surgery is complete.
One common technique for closing a treatment site such as a puncture after a catheterization procedure has been completed includes applying manual pressure and pressure dressing on the puncture site until the puncture site is sealed by the natural coagulation of blood. Patients undergoing such procedures are often medicated with an anticoagulant such as heparin, thus requiring a nurse to apply external pressure to the puncture site for a lengthy period of time. This procedure may immobilize the patient for an extended period of time, resulting in great inconvenience, pain, anxiety, and discomfort for the patient. Also, additional time is required of the medical personnel and facilities. Furthermore, the pressure application technique may fail to prevent hemorrhage and this may be life-threatening. Moreover, a painful hematoma or bruise may develop at the puncture site because the vessel may continue to bleed internally until clotting blocks the opening in the vessel.
Other techniques for closing a treatment site after a surgical procedure such as catheterization include the use of staples or sutures that can be applied manually or by mechanical devices. One such mechanical device deploys needles through the puncture. The needles have sutures attached, which are subsequently tied to close the treatment site. The sutures can later be removed or can be of the type that dissolve as the healing process progresses.
Another method includes the use of a biocompatible glue that holds the treatment site closed so that the natural process of coagulation and healing can proceed. The biocompatible glue eventually disintegrates as the treatment site heals.
The treatment site closing techniques such as suturing, stapling, or gluing all require additional time to perform the procedures. Also, these techniques introduce foreign material into the body of the patient. Foreign material can increase the chance of infection or inflammatory response. In some cases, the body absorbs the foreign material during the process of disintegrating of the material and healing of the treatment site.
The manual pressure technique generally does not require the use of foreign materials. Relying on natural coagulation of blood to close the treatment site, however, can be time consuming and uncomfortable to the patient. As in any surgical procedure, a less invasive and faster procedure can lessen or minimize patient discomfort.